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Fexofenadine Hydrochloride

Dosage form
TABLET, FILM COATED
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Label updated
2017-12-01
Retrieved
2026-09-07
Active ingredients
FEXOFENADINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredient (in each tablet)

Fexofenadine hydrochloride USP, 60 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • •runny nose
  • •sneezing
  • •itchy, watery eyes
  • •itching of the nose or throat
Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

kidney disease. Your doctor should determine if you need a different dose.

When using this product

  • •do not take more than directed
  • •do not take at the same time as aluminum or magnesium antacids
  • •do not take with fruit juices (see Directions)

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

Other information
  • •Tamper Evident: do not use if foil seal under cap is missing, open or broken
  • •store between 20° to 25°C (68° to 77°F)
  • •protect from excessive moisture
Inactive ingredients

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

Questions or comments?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Marketed/ Packaged by: GSMS, Inc., Camarillo, CA 93012 USA

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 180 mg
30 43353-760-30
60 43353-760-53
90 XXXXX-XXX-60
120 XXXXX-XXX-70
180 XXXXX-XXX-80
240 XXXXX-XXX-90
270 XXXXX-XXX-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

[Image in the official label — see DailyMed source]


Cookeville, TN 38506

20171201JH

PRINCIPAL DISPLAY PANEL - 180mg

NDC 43353-760 - Fexofenadine HCl 180mg - Rx Only

[Image in the official label — see DailyMed source]

DailyMed Set ID: d0a79081-71e0-407d-876b-f4393fd4d1e5 · Version 1
NDC: 43353-760